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NCT ID: NCT01458470 Completed - Huntington Disease Clinical Trials

A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease

MITIGATE-HD
Start date: September 2011
Phase: Phase 2
Study type: Interventional

Huntington disease is characterized by difficulties in movement and thinking. Psychological disturbances including irritability, aggression, loss of interest, depressed mood, obsessions and compulsions, also represent common symptoms of HD. These symptoms are distressing both for HD patients and their caregivers, contribute to the loss of ability to carry out activities of daily living, and present a major treatment challenge for physicians. The goal of this study is to determine the effect of memantine on movement, thinking and emotional difficulties in HD patients. Memantine is a medication originally approved for the treatment of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD), which has also recently been shown to improve the behavioural and neuropathological symptoms in a mouse model of Huntington Disease (HD).

NCT ID: NCT01458262 Completed - Clinical trials for Cerebral Desaturation

Observational Study on the Clinical Impact of Desaturation During Liver Surgery

Start date: September 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine the clinical impact of cerebral and systemic desaturation during liver transplantation and resection on post-operative complications.

NCT ID: NCT01458223 Completed - Clinical trials for Postoperative Infection

The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain

PARISS
Start date: October 2011
Phase: Phase 4
Study type: Interventional

Post-operative antibiotics for infection prophylaxis are routinely given to most surgical patients, and for orthopaedic surgery patients, the standard of care is treatment for 24 hours following any elective procedure (1). The most concerning risk for insufficient antibiotic coverage in the post-operative period is the development of a complicated infection requiring irrigation and debridement or revision surgery. Moreover, recovery from surgery is usually delayed in patients that have postoperative wound infections leading to increased resource utilization and increased economic cost for the health care system. It is clear that prophylactic antibiotic therapy is necessary in the immediate post-operative period, but the length required continues to be debated. Orthopaedic patients undergoing elective spine surgeries often require the placement of a hemovac drain which applies gentle suction to remove excess fluid/blood and to promote healing. Wound drains, however, may also increase the risk of post-operative infection because they expose the "clean" interior aspect of the wound to the "dirty" exterior area around the wound. Given this additional focus of infection, it is unknown whether prolonged antibiotic therapy post-operatively is needed to decrease the rate of infection in this population (2,3). There is sparse literature evaluating the effectiveness of prolonged antibiotic therapy in decreasing complicated post-operative infection requiring irrigation and debridement in this population (1,4). To our knowledge, there are no recent studies comparing prophylactic antibiotics for 24 hours only post-operatively versus 24 hours after removal of the drain. In fact, a recent evidence-based review of the literature by the North American Spine Society highlighted the need for research in this area (5). The proposed study will compare two patient populations who will receive various lengths of post-operative antibiotics. One will receive only 24 hours worth, and the other will receive antibiotics for 72 hours after surgery and the rate of complicated infection compared between the two. The absence of a demonstrable difference suggests that antibiotic prophylaxis for only 24 hours immediately post-operatively is sufficient for all elective spine patients undergoing posterior spine procedures requiring the placement of a hemovac drain.

NCT ID: NCT01457924 Completed - Multiple Sclerosis Clinical Trials

Ofatumumab Subcutaneous Administration in Subjects With Relapsing-Remitting Multiple Sclerosis

MIRROR
Start date: November 1, 2011
Phase: Phase 2
Study type: Interventional

Ofatumumab is a novel Immunoglobulin 1ĸ ( IgG1ĸ) lytic monoclonal antibody (mAb) that specifically binds to the human Cluster of Differentiation 20 (CD20) antigen of which expression is restricted to B lymphocytes from the pre-B cell stage to the plasmacytoid immunoblast stage only. A recent trial with an anti-CD20 mAb (rituximab) demonstrated that targeting B-cells reduces the number of gadolinium-enhancing (GdE) T1 lesions and the relapse rate in relapsing-remitting multiple sclerosis (RRMS). Ofatumumab has been shown to be both well tolerated and efficacious in several indications, including a small, placebo-controlled trial in RRMS using an intravenous (IV) formulation. This double-blind, placebo-controlled, parallel-group study will investigate the safety and efficacy of a subcutaneous formulation of ofatumumab in the treatment of subjects with RRMS. The primary objective of the study is to investigate the efficacy as assessed by magnetic resonance imaging. Other objectives will include evaluation of tolerability/safety, dose-response relationship, pharmacokinetics, pharmacodynamics, exposure-response, as well as other clinical endpoints.

NCT ID: NCT01457846 Completed - Gastric Cancer Clinical Trials

Efficacy and Safety of AZD4547 Versus Paclitaxel in Advanced Gastric or Gastro-oesophageal Junction Cancer Patients

SHINE
Start date: November 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have increased number of FGFR2 gene.

NCT ID: NCT01457781 Completed - Clinical trials for Pulmonary Hypertension

Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH)

PAH
Start date: April 2012
Phase: Phase 2
Study type: Interventional

This is a Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-on Therapy in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH).

NCT ID: NCT01457768 Completed - Clinical trials for Hepatitis C, Chronic

A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

Start date: December 19, 2011
Phase:
Study type: Observational

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

NCT ID: NCT01457755 Completed - Clinical trials for Hepatitis C, Chronic

Gilead Sustained Virologic Response (SVR) Registry

Start date: April 13, 2012
Phase:
Study type: Observational

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

NCT ID: NCT01457677 Completed - Clinical trials for Major Depressive Disorder

ARTDeCo Study: A Study of RO4995819 in Patients With Major Depressive Disorder And Inadequate Response to Ongoing Antidepressant Treatment

Start date: December 2011
Phase: Phase 2
Study type: Interventional

This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4995819 as adjunctive therapy in patients with major depressive disorder having inadequate response to ongoing antidepressant treatment. Patients will be randomized to receive once daily doses of 5 mg, 15 or 30 mg of RO4995819 or matching placebo. The anticipated time on study treatment is 6 weeks.

NCT ID: NCT01456949 Completed - Clinical trials for Paroxysmal Atrial Fibrillation (PAF)

Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)

STOP AF PAS
Start date: June 26, 2012
Phase: N/A
Study type: Interventional

The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front® Cardiac CryoAblation System.